CORVITOL 50mg and 100mg tablets

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER CORVITOL 50mg and 100mg tablets METOPROLOL TARTRATE This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine, which outlines the conditions under which the medicine should be used and information on its known safety The product information may be updated several times within its shelf life, and there could be differences between the version of information shown here and other information in the public domain or in the package insert This leaflet may not contain all the information about the medicine or the information may not be the most up to date version for this product If you have any questions or are not sure about anything, ask your doctor or pharmacist Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you only Do not pass it on to others It may harm them, even if their signs of illness are the same as yours If you get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet What is in this leaflet? 1. What Corvitol tablets are and what they are used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 1. WHAT CORVITOL TABLETS ARE AND WHAT THEY ARE USED FOR Metoprolol Tartrate belongs to a group of medicines called beta-blockers. It is used to treat: high blood pressure angina pectoris (pain in the chest caused by blockages in the arteries to the heart) irregular heart rhythm (arrhythmia) the symptoms caused by an overactive thyroid gland (thyrotoxicosis) It is used to prevent: migraine heart damage and death due to heart attacks. 2. BEFORE YOU TAKE Do not take Corvitol tablets and tell your doctor if you: are allergic (hypersensitive) to metoprolol, other beta-blockers or any of the other ingredients in Corvitol tablets suffer with heart conduction or rhythm problems have severe or uncontrolled heart failure are in shock caused by heart problems

2 suffer with blocked blood vessels, including blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue) have a slow heart rate or have suffered a heart attack which has been complicated by a significantly slow heart rate suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal s angina) suffer with untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney) suffer from increased acidity of the blood (metabolic acidosis) have low blood pressure have or have had breathing difficulties or asthma including COPD (Chronic Obstructive Pulmonary Disease causing cough, wheezing or breathlessness, phlegm or increase in chest infections) suffer with diabetes associated with frequent episodes of low blood sugar (hypoglycaemia) have liver or kidney disease or failure have difficulties in passing urine have low levels of potassium (hypokalaemia) or sodium (hyponatraemia) in your blood have high levels of calcium (hypercalcaemia) suffer with gout due to high levels of uric acid (hyperuricaemia) in your blood causing crystals to deposit in joints of hands or feet causing pain are given other medicines for blood pressure by injection especially verapamil, diltiazem or disopyramide. Take special care with Corvitol tablets and tell your doctor if you: have a history of allergic reactions have diabetes mellitus (low blood sugar levels may be hidden by this medicine) suffer from treated phaeochromocytoma (high blood pressure due to tumour near the kidney) have an overactive thyroid (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite or weight loss may be hidden by this medicine) have or have suffered from psoriasis (severe skin rashes) have a slow heart rate or blood vessel disorder have controlled heart failure have impaired liver or kidney function have liver cirrhosis are elderly. Taking other medicines Do not take Corvitol tablets if you are already taking: monoamine oxidase inhibitors (MAOIs) for depression other blood pressure lowering medicines such as verapamil, nifedipine and diltiazem disopyramide or quinidine (to treat irregular heartbeat (arrhythmia) Before taking Corvitol tablets, tell your doctor if you are taking or have taken recently any of the following medicines or are taking any non prescribed medicines: cimetidine (to treat stomach ulcers) hydralazine, clonidine or prazosin (to treat high blood pressure) amiodarone and propafenone (for irregular heart rhythm) tricyclic antidepressants (to treat depression) barbiturates (to treat epilepsy) phenothiazines (for mental illness) anaesthetics such as cyclopropane or trichloroethylene aldesleukin (to treat some cancers, particularly cancer of the kidney) alprostadil (to treat erectile dysfunction) anxiolytics or hypnotics (e.g. temazepam, nitrazepam, diazepam) indometacin or celecoxib (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)) rifampicin (antibiotic) or terbinafine (antifungal) cocaine oestrogens such as a contraceptive pill or hormone replacement therapy

3 corticosteroids (e.g. hydrocortisone, prednisolone) other beta-blockers e.g. eye drops. adrenaline (epinephrine) or noradrenaline (norepinephrine), used in anaphylactic shock or other sympathomimetics medicines used to treat diabetes lidocaine (a local anaesthetic) moxisylyte (used in Raynaud s syndrome) mefloquine (to treat malaria) tropisetron (to prevent nausea and vomiting) xanthines such as aminophylline or theophylline (to treat asthma) medicines to treat migranes such as ergotamine cardiac glycosides e.g. digoxin (to treat heart conditions) hydroxychloroquine (to treat rheumatoid arthritis) diphenydramine (sedative antihistamine). Pregnancy and breast-feeding Corvitol tablets are not recommended during pregnancy or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Sugar intolerance If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose. Alcohol You are advised to avoid alcohol whilst taking this medicine. Alcohol may increase the blood pressure lowering effect of Corvitol tablets. Driving and using machines Corvitol tablets may make you feel tired and dizzy. Make sure you are not affected before you drive or operate machinery, particularly after changing to another medicine or if taken with alcohol. Anaesthetics and surgery If you are going to have an operation or an anaesthetic, please tell your doctor or dentist that you are taking Corvitol tablets, as your heart beat might slow down too much. 3. HOW TO TAKE Always take Corvitol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Swallow the tablet whole. Usual doses: High blood pressure: Initially 100mg metoprolol tartrate daily. The dose may be increased to 200mg daily in single or divided doses. Angina: mg metoprolol tartrate two or three times daily. Irregular heart beats (arrhythmia): 50mg metoprolol tartrate two or three times daily. The dose may be increased to 300mg daily in divided doses. Heart attacks: 50mg metoprolol tartrate every six hours. The usual maintenance dose is 200mg daily in divided doses. Overactive thyroid gland (thyrotoxicosis): 50mg metoprolol tartrate four times daily.

4 Prevention of migraine: mg metoprolol tartrate daily in divided doses (in the morning and evening). Children: Not recommended. Patients with impaired kidney or liver function: In such cases the dose should be adjusted. Always follow your doctor s advice. If you take more Corvitol tablets than you should If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Symptoms of overdose are low blood pressure (fatigue and dizziness), slow pulse, heart conduction problems, heart failure, shock caused by heart problems, cardiac arrest, shortness of breath, unconsciousness, coma, feeling and being sick, blue colouring of the skin, low blood sugar levels and high levels of potassium in the blood. If you forget to take Corvitol tablets If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed. If you stop taking Corvitol tablets Do not suddenly stop taking Corvitol tablets as this may cause worsening of heart failure and increase the risk of heart attack. Only change the dose or stop the treatment in consultation with your doctor. 4. POSSIBLE SIDE EFFECTS Like all medicines, Corvitol tablets can cause side effects, although not everybody gets them. Stop treatment and contact a doctor at once if you have the following symptoms of an: allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Common (occurs in less than 1 in 10 users): tiredness, dizziness, headache, a slow heart rate, feeling faint on standing due to low blood pressure, shortness of breath with or without strenuous physical activity, feeling or being sick, stomach pain Rare (occurs in less than 1 in 1,000 users): depression, nightmares, inability to think clearly, sleepiness or difficulty in sleeping, tingling or pins and needles, difficulty breathing, heart failure, irregular heart rate, palpitation, water retention causing swelling, Raynaud s phenomenon (causing pain, numbness, coldness and blueness of the fingers), diarrhoea or constipation, skin rash, muscle cramps Very rare (occurs in less than 1 in 10,000 users): changes in the results of blood tests, effects on blood clotting causing easy or unexplained bruising, changes in personality, hallucinations, visual disturbances, dry or irritated eyes, ringing in the ears, loss of hearing with high doses, heart conduction problems, chest pain, gangrene in patients with severe poor circulation, runny nose, dry mouth, weight gain sensitivity to light, increased sweating, hair loss, worsening or new psoriasis, joint inflammation (arthritis), disturbances of sexual desire and performance, changes in liver function tests. Not known: worsening or development of limping, hepatitis (symptoms include fever, sickness and yellowing of the skin or whites of the eyes), Peyronie s syndrome (bending of the penis), symptoms of high levels of the thyroid hormone or low blood sugar may be hidden, confusion, increase in blood fats or decrease in cholesterol. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5 5. HOW TO STORE Keep out of the reach and sight of children. Store below 25 C in a dry place. Protect from light. Do not take the tablets after the expiry date which is stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. This leaflet was last revised in April 2014